Variations of High Sensitivity Troponin T in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 497
- 试验地点
- 1
- 主要终点
- Level of cardiac high sensitive Troponin T in umbilical cord blood
研究概览
简要总结
Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.
详细描述
- Approximately 400 subjects will be recruited over a planned recruitment period of 2 months. During labour, or pre natal hospitalization, information about the study will be given to every mothers by the midwife or the pediatrician. Absence of opposition will be notified in the medical file.
- At birth, every child born alive is possibly eligible for this study, if he doesn't meet the exclusion criteria.
- After clamping the umbilical cord, the midwife realizes the systematic sample for assessment of pH and lactate. If the mother did not object to the study, the midwife will use 200µl of this very same sample to assess Troponin T blood level. This sample goes to the same laboratory to be analyzed. The blood sample for troponin T measurement must be brought to the laboratory within 2 hours, just as pH and lactate must be. The midwife in charge of this patient also fills a form with informations from the patient's medical file. This form is anonymized for the study.
- Samples will not be stored, remaining swab after analysis will be destructed.
- Before discharge, all children undergo a medical exam by a pediatrician, whether they are in maternity or in neonate. The pediatrician who examines the child fills a second form that summarizes the noteworthy events of his hospital journey.
Subjects have the right to withdraw from the study at any time for any reason. If one of the parents wishes to withdraw from the study after the first Troponin T measurement is made, we will ask for their permission to use the collected data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Every newborn, born alive in René Dubos maternity, without regarding the way of birth.
- •Absence of malformative syndromes or genetic abnormalities in prenatal echographies
- •Absence of parental opposition
排除标准
- •Multiple pregnancies
- •Post natal discovery of malformative syndromes or genetic abnormality. All congenital heart diseases will be excluded.
- •Parental opposition at any time of the study
结局指标
主要结局
Level of cardiac high sensitive Troponin T in umbilical cord blood
时间窗: At birth - Time 0
T level will be analyzed by the biochemistry laboratory and collected by a study investigator.
次要结局
- Noticeable events during pregnancy ; Delivery conditions(Within the two hours following birth)
- Noticeable events in post partum(Before discharge)